In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
1/16/2025
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Trade Secrets
Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more
12/19/2024
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Trade Secrets
Recent reporting by the Financial Times shows that valuations and funding for biotech companies has fallen significantly, as “just nine biotech companies have listed in the U.S. this year, raising a total of $1bn … almost 60...more